IMC are currently supporting a UK head quartered client to hire a technical Clinical Development expert to join their fast-growing team. The company Support Global Pharma & Biotech clients with Product Development & Regulatory services. Their international team offers strategic and operational support in the fields of Non-Clinical/Toxicology, CMC, Clinical/Medical and Regulatory.
You will be a technical Clinical Strategy expert joining the team on a full-time basis as a Principal Consultant (Senior Manager / Director / VP of Reg / Head of Department equivalent). The position requires that you have established experience in working independently and leading technical discussions on a range of clinical development topics in compliance with current regulatory requirements. You will be competent in direct hands-on clinical writing and review of documents for regulatory submissions.
This is an excellent opportunity to progress your career at a growing global Regulatory Consultancy. You will have the opportunity to play a key role in the development and mentoring of staff whilst providing high-quality regulatory technical advice and product development strategies for clients.
Provide strategic, technical, and regulatory advice/services to clients in clinical development of human medicinal products, across a wide range of therapeutic indications & activities
Provide innovative drug development plans, data gap analysis and international regulatory strategies from a Clinical perspective for complex products within the changing regulatory environment
Support company Business Development activities including:
Sales/marketing introductions
Preparation of project proposals & educational materials
Review written estimates & quotations for accuracy
Contribute to technical authorship and review of development regulatory documents, focusing on FDA, EMA & MHRA activities
Provide technical leadership to other members of the consultancy team, including other Principal and Senior Consultants
Represent clients in regulatory agency interactions and provide regulatory solutions to agency objections
Ensure delivery of project goals within agreed timelines and project budgets
Identify and generate additional business opportunities from current Clients through exceeding expectations relating to the quality, delivery time and cost of services
Educate clients on current regulatory trends and expectations
Establish and maintain a high level of technical knowledge in product development and international regulatory affairs
Challenge the regulatory boundaries from a technical and scientific standpoint
Lead meetings with internal and external stakeholders on matters related to any current and/or future projects, contracts, or new business opportunities
Provide strategic input/support to company Directors and the company's growth plan
Line manage individual contributors, and in doing so, provide ongoing coaching, mentoring and companywide training (when required)
The role will be affiliated to their UK office
The role will be flexible, working from home with a minimum of one office-based day per month
The selected candidate will report directly to the Head of Clinical
Skills and Experience
A high scientific calibre with a life science focused BSc (or equivalent), and a higher degree in a biomedical field or equivalent (e.g., a life science focused MSc or preferably a PhD)
At least fifteen years of drug development experience, with at least five years in biotechnology and regulatory affairs
Clinical development experience across a range of therapeutic indications/disease areas
Preference for candidates with significant experience in drug development covering Europe, UK, and the United States
Proven ability in defining and delivering creative scientifically driven solutions to technical development and regulatory issues
Preference for candidates who have direct experience in providing strategic regulatory planning for the delivery of industry development goals, up to marketing authorisation
Experience in negotiation with multinational regulatory authorities including, as a minimum, European, UK and US authorities.
Proven ability to deliver education via scientific conference presentations in chosen field and training of subordinates
A professional manner and presentable appearance for meeting customers/clients
Ability to work in a proactive and autonomous manner as well as leading a global team, to ensure high-quality of deliverables
Ability to balance competing priorities and complete work within a set timeframe
Exemplary organisational skills with a high level of attention to detail
Exemplary verbal communication and presentation skills in English
High level of computer literacy and competency in MS Office programs
Willingness to work flexible hours and travel for short periods, sometimes at short notice, within the Netherlands, Europe, UK or internationally.
Salary & Benefits Include
A Competitive Salary
Company Bonus Scheme
26 Days Holiday Plus additional days for Birthday & Work Anniversary & all UK public holidays
5% employer pension contribution
Private Healthcare
Employee Assistance Programme
Employee Ownership Trust Scheme